On September 8, 2026 InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate clinical trials for ICP-B381, the novel bispecific ADC targeting PSMA and STEAP1, for the treatment of solid tumors including prostate cancer. ICP-B381 is InnoCare’s first bispecific ADC to enter the clinic and the third ADC to enter clinical trials.

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ICP-B381 is InnoCare’s first bispecific ADC built on its proprietary ADC technology platform, comprising a humanized anti- PSMA/STEAP1 antibody conjugated to a potent proprietary payload via a next-generation irreversible linker. By engaging PSMA and STEAP1 simultaneously, ICP-B381 is designed to address heterogeneous tumor cell populations and reduce the risk of tumor escape, potentially benefiting a broader range of patients. In preclinical studies, ICP-B381 demonstrated robust and dose-dependent antitumor activity in a 22Rv1 human prostate cancer xenograft model, outperforming the corresponding single-target PSMA-ADC and STEAP1-ADC at the same dose, with favorable tolerability.

PSMA and STEAP1 are significantly overexpressed in prostate cancer cells with limited expression in normal tissue, making them highly promising therapeutic targets, particularly in metastatic castration-resistant prostate cancer (mCRPC). Currently, no bispecific ADC targeting PSMA and STEAP1 has been approved for marketing globally.

Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, said, "The IND approval of ICP-B381, our first bispecific ADC, is an important milestone for our proprietary ADC platform and reflects the progress we have made in building differentiated ADC candidates. We look forward to advancing ICP-B381 into the clinic and to developing more differentiated ADC candidates to address the needs of patients globally."

Prostate cancer is one of the most common malignancies among men worldwide with an estimated 1.5 million new cases in 2024. It is the most frequently diagnosed cancer in men in nearly two-thirds of the world’s countries.

(Press release, InnoCare Pharma, SEP 8, 2026, View Source [SID1234670658])

On September 8, 2026 BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T cell therapies to treat tumors in the central nervous system, reported that the company has closed a $116 million Series A financing. An undisclosed private family fund and foundation, aligned with BrainChild Bio’s mission, led the financing round, with participation from the company’s initial investor, Seattle Children’s, and new investor WRF Capital.

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Proceeds from the Series A financing will be used to support the ILLUMINATE Phase 2 study, a pivotal clinical trial (NCT07680439) to evaluate BCB-276, the company’s investigational B7-H3-targeted autologous CAR T cell therapy, for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and aggressive pediatric brainstem tumor with limited treatment options. In addition, these funds will support the continued development of BCB-214, the company’s triple-targeting CAR T cell therapy being advanced to initial clinical testing in glioblastoma. BrainChild Bio’s pipeline programs leverage the company’s CAR T cell therapy platform to treat tumors of the central nervous system (CNS), based on an exclusive license to technology developed at Seattle Children’s, announced in December 2023.

"Our path to building BrainChild Bio has led us to secure the support of a unique and committed syndicate of investors who share our mission to prioritize therapeutic innovation for children with cancer, while also rapidly advancing new science that can change the course of brain cancers for a wider population," said Steven Brugger, Chief Executive Office of BrainChild Bio. "We believe the time is right to show the breakthrough potential for our CAR T cell therapeutic approach with BCB-276 for DIPG which is a devastating pediatric brain cancer, as well as accelerate our efforts to advance other CAR T cell therapies for pediatric and adult brain tumors."

Since the company’s launch, BrainChild Bio has advanced BCB-276 into a registration-stage clinical development program for DIPG. Building on the foundational clinical experience generated at Seattle Children’s, the company optimized the therapeutic product for late-stage clinical development, established the manufacturing, quality, and regulatory infrastructure required to support a registrational program. These efforts culminated in the initiation of the ILLUMINATE Phase 2 clinical trial, a pivotal registrational study designed to support a future Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for the treatment of DIPG.

"This financing enables us to chart our path forward to serve the children and families afflicted with devastating brain tumors and represents a new paradigm for treating CNS brain tumors in children and adults," stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. "Our team at BrainChild Bio is steadfast in its commitment to harness CAR T cell technology in CNS tumors and we are uniquely positioned to do so."

About Diffuse Intrinsic Pontine Glioma (DIPG) and Application of CAR T cell Therapies

Diffuse intrinsic pontine glioma (DIPG) is a primary high-grade brain tumor that arises in the pons and is uniformly fatal. DIPG affects approximately 300 children per year in the U.S. with the majority of diagnoses made in children between 5 and 10 years of age. Current standard-of-care treatment remains limited to palliative focal radiation therapy which results in a median overall survival of only about 11 months from diagnosis.1

BrainChild Bio’s autologous CAR T cell therapy offers the potential to overcome barriers to effective therapies for DIPG, including the precarious location of the tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains relatively intact during tumor progression. BrainChild Bio’s CAR T cell therapies are engineered to be administered by locoregional delivery directly into the cerebrospinal fluid, permitting infused CAR T cells to directly access the tumor bed using an in-dwelling reservoir-catheter. This allows for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, repetitive infusions of CAR T cells for more durable and sustained efficacy, and local therapeutic administration to minimize on-target, off-tumor toxicities.

(Press release, BrainChild Bio, SEP 8, 2026, View Source [SID1234670657])

On September 8, 2026 BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T cell therapies to treat tumors in the central nervous system, reported the initiation of a pivotal Phase 2 clinical trial to evaluate BCB-276, its investigational B7-H3-targeted autologous CAR T cell therapy, for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and aggressive pediatric brainstem tumor with limited treatment options.

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The ILLUMINATE Phase 2 clinical trial (NCT07680439) is an open label, single-arm study to evaluate the efficacy and confirm the safety of BCB-276 in children and young adults with newly diagnosed DIPG following initial standard-of-care focal radiation therapy. The trial is designed as a single arm, pivotal Phase 2 registrational trial to accelerate the path to submit a biologics license application (BLA) for BCB-276 for the treatment of DIPG, based on alignment with the U.S. Food and Drug Administration (FDA). BCB-276 has also received Fast Track designation, further supporting an expedited development and regulatory review pathway. The multi-center study will be conducted at leading pediatric neuro-oncology centers throughout the United States. Site activation is complete or underway across all six selected and qualified study sites.

"Bringing this pivotal Phase 2 study forward for children battling DIPG has been our steadfast purpose at BrainChild Bio and represents the hard work of our team and the opportunity to advance our mission to combat pediatric brain cancer," stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. "We aspire to bring breakthrough medicines to these children, providing hope for cures that are safe and preserve quality of life."

As an autologous CAR T cell therapy, BCB-276 is manufactured from the participant’s own immune cells, and the treatment is administered by locoregional delivery directly into the cerebrospinal fluid using an indwelling reservoir-catheter device. Patients in the study receive BCB-276 approximately every 2 weeks for a planned course of up to a total of 15 doses over approximately 7-8 months. The primary endpoint of the study is overall survival, and secondary endpoints include safety and tolerability, progression free survival, and radiographic response.

"Children and families facing a diagnosis of DIPG urgently need new treatment options. While we recognize the significant challenges in developing new therapies for DIPG, we are hopeful that our ILLUMINATE study will bring us closer to transforming the treatment landscape and delivering a meaningful therapeutic advance for these children," said Cori Abikoff, MD, Vice President of Clinical Development. "The pivotal Phase 2 ILLUMINATE study represents an important step in evaluating the potential of BCB-276 for children with newly diagnosed DIPG. We are partnering closely with leading pediatric neuro-oncology investigators and study sites to conduct this trial with the urgency and scientific rigor that this aggressive brain cancer demands."

BrainChild Bio’s autologous B7-H3 CAR T cell therapy is based on a CAR T cell therapy that Dr. Michael Jensen and his team developed at Seattle Children’s for the treatment of DIPG, which was exclusively licensed to BrainChild Bio. In an FDA authorized clinical study, called the BrainChild-03 Phase 1 trial (NCT04185038), the CAR T cell therapy exhibited a manageable safety profile in the context of outpatient administration and provided preliminary evidence of encouraging overall survival outcomes. The results of this trial were published in Nature Medicine.

About Diffuse Intrinsic Pontine Glioma (DIPG) and Application of CAR T cell Therapies

Diffuse intrinsic pontine glioma (DIPG) is a primary high-grade brain tumor that arises in the pons and is uniformly fatal. DIPG affects approximately 300 children per year in the U.S. with the majority of diagnoses made in children between 5 and 10 years of age. Current standard-of-care treatment remains limited to palliative focal radiation therapy which results in a median overall survival of only about 11 months from diagnosis.1

BrainChild Bio’s autologous CAR T cell therapy offers the potential to overcome barriers to effective therapies for DIPG, including the precarious location of the tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains relatively intact during tumor progression. BrainChild Bio’s CAR T cell therapies are engineered to be administered by locoregional delivery directly into the cerebrospinal fluid, permitting infused CAR T cells to directly access the tumor bed using an in-dwelling reservoir-catheter. This allows for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, repetitive infusions of CAR T cells for more durable and sustained efficacy, and local therapeutic administration to minimize on-target, off-tumor toxicities.

(Press release, BrainChild Bio, SEP 8, 2026, View Source [SID1234670656])

On September 8, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported its participation in the Morgan Stanley 24th Annual Global Healthcare Conference being held at the New York Marriott Marquis in New York, NY. Management will participate in a fireside chat on Tuesday, September 15, 2026, at 1:05 pm Eastern Time and will also participate in one-on-one investor meetings.

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A live audio webcast of the event will be available online at Erasca.com/events. An archived replay of the event will be available for 30 days following the webcast at Erasca.com/events.

(Press release, Erasca, SEP 8, 2026, View Source [SID1234670655])

On September 8, 2026 Cloverleaf Bio ("Cloverleaf"), an RNA therapeutics company developing a novel class of engineered transfer RNA (tRNA) based payloads for cancer, reported the closing of a $33 million seed financing round. The upsized and oversubscribed round was led by 4BIO Capital and includes meaningful participation from strategic investors AbbVie Ventures, Eli Lilly and Company, and Boehringer Ingelheim Venture Fund, alongside Draper Associates, Mission BioCapital, and American Cancer Society BrightEdge.

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The simultaneous participation of three major pharmaceutical venture arms at pre-clinical stage reflects strong industry interest in both the scientific platform and the founding team. The proceeds of the fundraise will be used to advance Cloverleaf’s two lead programs: an inhibitory tRNA asset targeting hepatocellular carcinoma through early clinical testing and an antibody-tRNA conjugate (ATC) asset targeting colorectal cancer through preclinical development.

Cloverleaf’s platform is built around selective and durable inhibition of multiple RNA-modifying enzymes, a class of proteins that cancer cells become abnormally dependent on as they proliferate.

Austin Draycott, PhD, CEO and Co-Founder of Cloverleaf Bio, said "We are excited to secure this financing to advance a new generation of cancer therapeutics. We’re grateful to 4BIO Capital for leading this round, and to attract major strategic investors, including AbbVie Ventures, Lilly, and Boehringer Ingelheim Venture Fund at this stage reflects the level of scientific interest in this approach. We look forward to delivering the data that will test that conviction. We would also like to acknowledge the early support Cloverleaf received from the National Cancer Institute Small Business Innovation Research / Small Business Technology Transfer program. Federally funded research was foundational to getting this platform off the ground, and we’re proud to build on that public investment as we move toward the clinic."

Dima Kuzmin, Co-founder and Managing Partner at lead investor 4BIO Capital said: "Cloverleaf reflects the core thesis of 4BIO: backing transformative frontier science that has the potential to become an entirely new class of cancer therapeutics with applicability to every major cancer of unmet need. The team at Cloverleaf have built a highly promising platform from a first-principles insight into a mechanism that the field has largely taken for granted for sixty years. The preclinical data on potency and selectivity is compelling, and the strategic interest from three major pharma venture arms at seed reflects how seriously the broader industry is taking this approach. We are proud to lead this round and look forward to supporting the team as they advance toward the clinic."

Christina Vorvis, Ph.D., Director at AbbVie Ventures, said: "Cloverleaf’s platform reflects the kind of bold and novel scientific approaches we seek to advance. Our support of Cloverleaf, from its beginnings as a Yale spinout through its current efforts to develop next-generation RNA therapeutics, reflects how AbbVie Ventures works with emerging companies. Beyond investing capital, we engage as dedicated collaborators early on, bringing scientific and operational expertise to help turn promising science into potential new therapies."

Matthias Samwer, Director, at Boehringer Ingelheim Venture Fund, said: "Cloverleaf combines deep expertise in RNA biology with a highly innovative approach to tackling cancer. We believe its engineered tRNA platform has the potential to create an important new class of cancer medicines, and we are excited to support the company as it advances toward the clinic."

Differentiated Preclinical Profile

In preclinical studies, Cloverleaf’s lead compound, CLB-001, demonstrated significantly greater potency and selectivity for cancerous cells over healthy cells. The compound retains activity in cancer cell lines resistant to both frontline chemotherapy and current-generation ADC payloads, a meaningful finding given that treatment resistance is a major clinical challenge in colorectal cancer. CLB-001 also outperformed frontline standard of care in both hepatocellular carcinoma and lung adenocarcinoma models at substantially lower doses. Tolerability studies in animals showed no increases in markers of liver damage and no signs of systemic toxicity across the dose range tested.

This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Project No 1R44CA295426

(Press release, Cloverleaf Bio, SEP 8, 2026, View Source [SID1234670654])